Apotex
Associate, Master of Veterinary Science,
M. Pharm
Job Summary
Working
independently under the direction of the Head - Global Medical Affairs, GBS,
brings toxicological expertise in the Risk Assessment process to support risk
assessment and Health Hazard Assessment (HHA) activities for the business as
required. Major stakeholders are Research and Development, Quality Assurance,
Safety Health & Environment and others
Job Responsibilities
Conducts
Health Hazard Assessments in a timely manner upon request with a high level of
autonomy.
Actively
conducts risk assessment activities for a variety of situations from a
toxicological perspective when needed.
Establishes
acceptable and/or tolerable daily intakes for substances in question through
review or calculations.
Identifies
No Observed Effect Levels (NOEL) and No Observed Adverse Effect Levels (NOAEL),
Lethal Dose 50 (LD50) etc.
Generates
reports with a toxicological conclusion for the assessment in question based on
the literature, the circumstances and the results of studies, if undertaken,
based on sound toxicological science.
Regular
interactions with Regulators such as Health Canada, FDA, and other competent
Authorities in the EU and Australia to address toxicological issues in New Product
Submissions and Marketed Products.
Supports
Safety, Health and Environment with toxicological assessments when requested.
Supports
business units in GRDQ such as Global Project Management, Quality Assurance,
Formulation Development, Analytical Operations etc. bringing toxicological
expertise to bear.
Job Requirements
Education
Master
of Veterinary Science, M. Pharm,
Certification-
Diplomat American Board of Toxicology (preferred)
Knowledge,
Skills and Abilities
General
and Regulatory toxicology, Risk characterization, safety assessment, Consumer
products, Good Laboratory Practice, as a toxicologist in the area of drug
development.
Good
knowledge and skill in toxicological testing procedures for pesticides, new chemical
entities, IND requirements.
Good
knowledge and skill in risk assessment procedures for Medical products/Medical
devices.
Experience
>5-7
years of experience either in Toxicology CRO, Pharmaceutical industries,
Consumer safety assessment.
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